FDAFDA · Food and drugs·Recall number Z-1849-2012
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
Published June 27, 2012 · Recall initiated: October 12, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software Version 3.1.1 does not meet navigational accuracy.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- Nationwide Distribution including the states of CO, IN, and MN.
- Lot
- Serial Numbers: 125, 156, 234R.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.